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Serving 500+ biopharmaceutical companies globally:

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Generated: July 23, 2017

DrugPatentWatch Database Preview

Insulin detemir recombinant - Generic Drug Details

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What are the generic drug sources for insulin detemir recombinant and what is the scope of insulin detemir recombinant freedom to operate?

Insulin detemir recombinant
is the generic ingredient in five branded drugs marketed by Novo Nordisk Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin detemir recombinant has two hundred and twenty-nine patent family members in thirty countries.

There are thirty-eight drug master file entries for insulin detemir recombinant. Three suppliers are listed for this compound.

Summary for Generic Name: insulin detemir recombinant

Tradenames:5
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list3
Clinical Trials: see list5,396
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:insulin detemir recombinant at DailyMed

Pharmacology for Ingredient: insulin detemir recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYesRE46363► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes8,672,898► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNoRE43834► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo5,866,538► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005DISCNNoNo5,866,538► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin detemir recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 20056,011,007► Subscribe
Novo Nordisk Inc
LEVEMIR INNOLET
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-003Jun 16, 20056,011,007► Subscribe
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 20055,866,538► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 20055,866,538► Subscribe
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 20056,869,930► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin detemir recombinant

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,011,007 Acylated insulin► Subscribe
6,235,004 Injection syringe► Subscribe
6,582,404 Dose setting limiter► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
6,869,930 Acylated insulin► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: insulin detemir recombinant

Country Document Number Estimated Expiration
Brazil0014030► Subscribe
Canada2594764► Subscribe
World Intellectual Property Organization (WIPO)2007017052► Subscribe
South Africa9900714► Subscribe
European Patent Office1570876► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: INSULIN DETEMIR RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
C/GB04/036United Kingdom► SubscribePRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Julphar
Cantor Fitzgerald
Mallinckrodt
Queensland Health
Citi
Healthtrust
Accenture
UBS
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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